ARTISTETM SOLUTION WITH SYS VCIO


Device Classification Name

accelerator, linear, medical

510(k) Number K121295
Device Name ARTISTETM SOLUTION WITH SYS VCIO
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 nelson ave.
concord, 
CA 
94520

Applicant Contact christine dunbar
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 nelson ave.
concord, 
CA 
94520

Correspodent Contact christine dunbar
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 04/30/2012
Decision Date 06/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls